(252 days)
ABLATE-IQ™ assists physicians in identifying ablation targets, assessing proper ablation probe placement and visualizing treatment zones when used with the NEUWAVE Microwave Ablation System (NEUWAVE System). The software is not intended for diagnosis, to predict ablation volume, or to predict ablation success.
ABLATE-IQ™ formally known as Ablation Confirmation, is a Computed Tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE System. ABLATE-IQ™ is resident on the NEUWAVE Microwave Ablation System and is accessible to the physicians via a second, dedicated monitor with its own user interface separate from the ablation user interface. ABLATE-IO™ functions are controlled via a USB connected mouse. ABLATE-IQ™ connects to a facility PACS system and CT scanner and receives and sends CT, fused PET and MR images via the DICOM protocol over the hospital network. DICOM enables the integration of scanners, servers, workstations, printers, and network hardware from multiple manufacturers into an electronic PACS.
ABLATE-IQTM contains a wide range of image processing tools, including:
- · 2D image manipulation
- · 3D image generation (from 2D images)
- · 3D image manipulation
- · Region of interest (ROI)/target identification, segmentation, and measurement
- · Image-based detection of ablation probes manually placed by the user (physician)
- · Registration of multiple images into a single view
The provided text is a 510(k) Summary for the ABLATE-IQ™ device, formerly known as Ablation Confirmation. It outlines the device's description, modifications, comparison to a predicate device, and the summary of non-clinical and/or clinical tests.
However, the document focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria and detailed study results as one might find in a full clinical or performance study report. Therefore, I can extract information related to the device's testing and general claims of performance, but specific quantitative acceptance criteria and detailed study parameters (like sample size for test sets, number of experts, adjudication methods, MRMC studies, or training set details) are not explicitly provided in this 510(k) summary.
Here's the information that can be extracted and a clear indication of what is not available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states, "The ABLATE-IQ™ software passed all pre-determined acceptance criteria identified in the test plan." However, the specific pre-determined acceptance criteria and quantitative reported device performance are not listed. The document mentions general validation of software functions.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not provided. The document refers to "an established test plan" and "Design verification documents" but does not specify the number of cases or images used in the test set.
- Data Provenance: Not provided. There is no information about the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: Not indicated. The document states the software "assists physicians," suggesting a human-in-the-loop scenario, but it does not describe an MRMC study comparing human readers with and without AI assistance, nor does it provide an effect size.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: Not explicitly detailed. The text mentions "ABLATE-IQ™ was tested in accordance with an established test plan that fully evaluated all functions performed by the software." This would imply standalone testing of the algorithm's functions (e.g., probe identification, ROI segmentation, image manipulation), but specific performance metrics for these standalone functions are not presented. The device is described as assisting physicians, implying it's not purely standalone in clinical use.
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated. Given the description of the software's functions (e.g., identifying ablation targets, assessing probe placement, visualizing treatment zones post-ablation), the ground truth for features like probe identification and ROI/ablation zone segmentation would likely involve expert consensus on medical images (e.g., CT scans). However, the method for establishing this ground truth (e.g., expert consensus, pathology, outcome data) is not described.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not provided. This document is about verification and validation tests for substantial equivalence, not the development or training of an AI model.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not provided.
In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence through a comparison to a predicate device and a high-level summary of verification and validation testing. It confirms that the device passed its "pre-determined acceptance criteria" but does not disclose the specific criteria or the detailed methodology and results of the studies that would typically address the specific points you requested (sample sizes, expert qualifications, ground truth methods, MRMC studies, etc.). This level of detail is usually found in a more comprehensive clinical or performance study report, which is not part of this 510(k) summary.
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April 4, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
NeuWave Medical, Inc. % Allison Francis Regulatory Affairs Specialist 3529 Anderson Street MADISON, WI 53704
Re: K232227
Trade/Device Name: ABLATE-IQTM Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: March 4, 2024 Received: March 4, 2024
Dear Allison Francis:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K232227
Device Name ABLATE-IOTM
Indications for Use (Describe)
ABLATE-IO™ assists physicians in identifying ablation targets, assessing proper ablation probe placement and visualizing treatment zones when used with the NEUWAVE Microwave Ablation System (NEUWAVE System). The software is not intended for diagnosis, to predict ablation volume, or to predict ablation success.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the text 'K232227'. The text is in a simple, sans-serif font. The letters and numbers are all the same size and are evenly spaced. The 'K' is the only letter, and the rest of the text is numbers.
Image /page/3/Picture/1 description: The image shows the logo for NeuWave Medical. The logo consists of a green sphere with a white wave design on the left, followed by the text "NeuWave Medical" in a simple, sans-serif font. Below the company name, in smaller letters, it says "PART OF THE ETHICON™ FAMILY OF COMPANIES".
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submission Sponsor: NeuWave Medical Inc. 3529 Anderson Street Madison, WI 53704
April 3, 2024
FDA Establishment# 3008769756
Date:
Submission Contact: Allison Francis Regulatory Affairs Specialist Phone: 508-728-7585 Email: afranc52@its.jnj.com
Mohamed Shariff Director of Regulatory Affairs Phone: 856-449-9609 Email: msharif3@its.jnj.com
Device Identification
| Device Trade Name: | ABLATE-IQ TM |
|---|---|
| Common Name: | System, X-Ray, Tomography, Computed |
| Classification Name: | Computed tomography x-ray system |
| Device Class: | Class II |
| Product Code: | JAK |
| CFR Section: | 21 CFR 892.1750 |
Predicate Device
ABLATE-IQ™ is substantially equivalent to the following currently marketed device: Predicate Device - Ablation Confirmation (K192427) NeuWave Medical, Inc.
Indications for Use
ABLATE-IQ™ assists physicians in identifying ablation targets, assessing proper ablation probe placement and visualizing treatment zones when used with the NEUWAVE Microwave Ablation System (NEUWA VE System). The software is not intended for diagnosis, to predict ablation volume, or to predict ablation success.
ABLATE-IQTM 510(k) Summary Page 1 of 10
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Device Description
ABLATE-IQ™ formally known as Ablation Confirmation, is a Computed Tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE System. ABLATE-IQ™ is resident on the NEUWAVE Microwave Ablation System and is accessible to the physicians via a second, dedicated monitor with its own user interface separate from the ablation user interface. ABLATE-IO™ functions are controlled via a USB connected mouse. ABLATE-IQ™ connects to a facility PACS system and CT scanner and receives and sends CT, fused PET and MR images via the DICOM protocol over the hospital network. DICOM enables the integration of scanners, servers, workstations, printers, and network hardware from multiple manufacturers into an electronic PACS.
ABLATE-IQTM contains a wide range of image processing tools, including:
- · 2D image manipulation
- · 3D image generation (from 2D images)
- · 3D image manipulation
- · Region of interest (ROI)/target identification, segmentation, and measurement
- · Image-based detection of ablation probes manually placed by the user (physician)
- · Registration of multiple images into a single view
Modifications
This 510(k) was submitted to update the Ablation Confirmation software with the following modifications:
- · Planning (New Premium Feature that is optionally licensed for 3.2.0): Probe Insertion Path Planning is an optional feature that allows the user to pre-plan the location and trajectory of the probe(s) relative to a pre-defined target(s). Proposed Ablation Zone Display allows the user to try different combinations of time and power derived from ex-vivo animal tissue data to help users visualize proposed ablation zones with targets and does not provide a clinical representation of tissue to be ablated.
- · Reporting (New Premium Feature that is optionally licensed for 3.2.0): Generation of an electronic report containing procedural information (e.g., ablation time and power used), data related to the target, and the treatment zone dimensions is also a new optional software feature available. The resulting report can be stored to the Hospital PACS.
- · Workflow Updates (page combinations): Prior to 3.2.0, the software had ten steps the user was required to step through. In 3.2.0, the ABLATE-IQ™ navigation groups similar workflow steps together under 3 major workflow pages.
- · Profiles: The system can apply default settings for procedure selectable features and recall those in a procedure selectable way. The default settings do not control the NEUWAVE system nor probe output in any way.
- · Cybersecurity: New cybersecurity features were added for additional protection and compliance
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Comparison of Subject Device and Predicate Device
ABLATE-IQ™ software version 3.2.0 has the same or similar technological characteristics as the predicate device and therefore is substantially equivalent to the predicate device.
| Attribute | Subject DeviceABLATE-IQTMK232227 | Predicate DeviceAblation ConfirmationK192427 | Comparison |
|---|---|---|---|
| Manufacturer | NeuWave Medical | NeuWave Medical | Same |
| Product Code | JAK | JAK | Same |
| RegulationNumber | 892.1750 | 892.1750 | Same |
| Indicationsfor Use | ABLATE-IQTM assistsphysicians inidentifying ablationtargets, assessingproper ablation probeplacement andvisualizing treatmentzones when used withthe NEUWAVEMicrowave AblationSystem (NEUWAVESystem). The softwareis not intended fordiagnosis, to predictablation volume, or topredict ablationsuccess. | Ablation ConfirmationTM(AC), is a ComputedTomography (CT) imageprocessing softwarepackage available as anoptional feature for usewith the NEUWAVEMicrowave AblationSystem. AC is controlledby the user via anindependent userinterface on a secondmonitor separate fromthe NEUWAVEMicrowave AblationSystem user interface.AC imports images fromCT scanners and facilityPACS systems fordisplay and processingduring ablationprocedures. AC assistsphysicians in identifyingablation targets,assessing proper ablationprobe placement andconfirming ablationzones. The software isnot intended fordiagnosis. | Same, the subject deviceindications for use is thesame as the underlined textfrom the predicate device.The verbiage of theIndications for Use of thesubject device is slightlydifferent than the declaredpredicate as the text isbeing reduced for clarity.The change in verbiagedoes not alter the intendeduse of the device ascompared to the predicatedevice. |
| Attribute | Subject DeviceABLATE-IQTMK232227 | Predicate DeviceAblation ConfirmationK192427 | Comparison |
| ImageAcquisition | The system is capableof retrieving CT imagedata, conforming to theDICOM standard.Additionally, fused PETimages and MR images canbe imported for thecomparison scan feature. | The system is capableof retrieving CT imagedata, conforming to theDICOM standard.Additionally, fused PETimages and MR images canbe imported for thecomparison scan feature. | Same |
| 2D ImageManipulation | The system provides toolsto manipulate the 2Dimage data. The tool setincludes:Window/LevelPan/ZoomImage ScrollingPointmeasurement(HU andcoordinate)DistancemeasurementRotation | The system provides toolsto manipulate the 2Dimage data. The tool setincludes:Window/LevelPan/ZoomImage ScrollingPointmeasurement(HU andcoordinate)DistancemeasurementRotation | Same |
| 3D ImageGeneration | The system is able togenerate a 3D imagebased upon the 2Dimage series. | The system is able togenerate a 3D imagebased upon the 2Dimage series. | Same |
| 3D ImageManipulation | The system provides toolsto manipulate the 3Dimage rendering.These tools include:RotationPan/ZoomWindow/LevelDistance between tipswhen multiple probesare detected | The system provides toolsto manipulate the 3Dimage rendering.These tools include:RotationPan/ZoomWindow/LevelDistance between tipswhen multiple probesare detected | Same |
| Attribute | Subject DeviceABLATE-IQTM | Predicate DeviceAblation Confirmation | Comparison |
| K232227 | K192427 | ||
| Region ofInterest (ROI)Identification | The system allows theuser to semi-automatically defineregions of interest on CTimages. A single- step"undo" function wasadded to this feature. | The system allows theuser to semi-automatically defineregions of interest on CTimages. A single- step"undo" function wasadded to this feature. | Same |
| ROIMeasurements | The system allows theuser to assess the volumeof the defined ROIs. | The system allows theuser to assess the volumeof the defined ROIs. | Same |
| Desired MarginIdentification | The system allows the usersto draw on the ROI imagesto visualize a user-determined desired marginfor the ablation procedure. | The system allows theusers to draw on the ROIimages to visualize a user-determined desired marginfor the ablation procedure. | Same |
| Registration | The system can performdeformable registration ontwo distinct CT images.The user can manuallyadjust the results of theregistration process.Replaced 'RefineRegistration' capabilitywith a 'ManualRegistration' capability.When using the manualregistration, the user hasthe option of turning offthe deformations computedby the deformableregistration. | The system can performdeformable registration ontwo distinct CT images.The user can manuallyadjust the results of theregistration process.Replaced 'RefineRegistration' capabilitywith a 'ManualRegistration' capability.When using the manualregistration, the user hasthe option of turning offthe deformations computedby the deformableregistration. | Same |
| Attribute | Subject DeviceABLATE-IQTMK232227 | Predicate DeviceAblation ConfirmationK192427 | Comparison |
| ProbeIdentification | The system canautomatically identifyablation probes within thescan. ABLATE-IQTM candetect up to 3 probes.The software also enablesthe user to manually drawprobes. | The system canautomatically identifyablation probes within thescan. AC can detect up to3 probes.The software also enablesthe user to manually drawprobes. | Same |
| Probe PlacementAssessment | The system, using thedeformable registrationprocess, can visualize theposition of the ablationprobe(s) in relation to theROI. | The system, using thedeformable registrationprocess, can visualize theposition of the ablationprobe(s) in relation to theROI. | Same |
| Ablation ZoneAssessment | Using the same process asROI identification, thesystem allows the user tosemi- automaticallyidentify the ablation zonefollowing an ablationprocedure. | Using the same process asROI identification, thesystem allows the user tosemi- automaticallyidentify the ablation zonefollowing an ablationprocedure. | Same |
| Allows User toAccount forTissueContraction | Yes | Yes | Same |
| TissueContractionRanges - Liver | ABLATE-IQTM withV3.2.0 SW allows usersto apply 0%, 10%, 15%,20% or 30% tissuecontraction to identifiedtarget during the"Evaluate AblationZone" step in theworkflow orautomatically basedupon default settings. | Ablation Confirmationwith V3.1.0 SW allowsusers to apply 0%, 10%,15%, 20% or 30%tissue contraction toidentified target duringthe "Evaluate AblationZone" step in theworkflow orautomatically basedupon default settings. | Same |
| Attribute | Subject DeviceABLATE-IQTMK232227 | Predicate DeviceAblation ConfirmationK192427 | Comparison |
| TissueContractionRanges - Kidney | ABLATE-IQTM withV3.2.0 SW allows users toapply 0%, 10%, 15%,20% or 30% tissuecontraction to identifiedtarget during the"Evaluate Ablation Zone"step in the workflow orautomatically based upondefault settings. | Ablation Confirmationwith V3.1.0 SW allowsusers to apply 0%, 10%,15%, 20% or 30% tissuecontraction to identifiedtarget during the"Evaluate Ablation Zone"step in the workflow orautomatically based upondefault settings. | Same |
| TissueContractionRanges - Lung | ABLATE-IQTM withV3.2.0 SW allows users toapply 0%, 10%, 20%,30%, 40% or 50%tissue contraction toidentified target duringthe "Evaluate AblationZone" step in theworkflow orautomatically basedupon default settings | Ablation Confirmationwith V3.1.0 SW allowsusers to apply 0%, 10%,20%, 30%, 40% or 50%tissue contraction toidentified target duringthe "Evaluate AblationZone" step in theworkflow orautomatically basedupon default settings. | Same |
| Assessing thetechnical successof the ablationprocedure | Using the samedeformable registrationprocess, image set withablation zone can beoverlaid onto the imageset with the initial ROIsegmentation to helpphysicians determine thetechnical success of anablation procedure.Allow user to view theSet Up scan next to theEvaluate Ablation scan. | Using the samedeformable registrationprocess, image set withablation zone can beoverlaid onto the imageset with the initial ROIsegmentation to helpphysicians determine thetechnical success of anablation procedure.Allow user to view theSet Up scan next to theEvaluate Ablation scan. | Same |
| Attribute | Subject DeviceABLATE-IQ™K232227 | Predicate DeviceAblation ConfirmationK192427 | Comparison |
| Snapshots | User can takesnapshots of any viewand send to the facilityPACS for achieving, ifdesired. | User can take snapshotsof any view and send tothe facility PACS forachieving, if desired. | Same |
| Remote Viewing | No remote viewingcapability | No remote viewingcapability | Same |
| Orthogonal 2DViewing | Axial, Sagittal,Coronal, "Needle" and"Periscope"presentation options. | Axial, Sagittal, Coronal,"Needle" and"Periscope" presentationoptions. | Same |
| Workflow | 3 workflow pagesPrior to 3.2.0, thesoftware had ten stepsthe user was requiredto step through. In3.2.0, the ABLATE-IQ™ navigationgroups similarworkflow stepstogether under 3 majorworkflow pages. | 10 workflow pages | Different |
| Reporting | New optionalreporting featureadded for version 3.2.0software. | No reporting featureavailable. | Different |
| Profiles | The system can applydefault settings forprocedure selectablefeatures and recallthose in a procedureselectable way.The default settings donot control theNEUWAVE systemnor probe output inany way. | No profile featureavailable. | Different |
| Planning | New optional featureadded for softwareversion 3.2.0. | No planning featureavailable. | Different |
| Attribute | Subject DeviceABLATE-IQ™ | Predicate DeviceAblation Confirmation | Comparison |
| K232227 | K192427 | ||
| Cybersecurity | ABLATE-IQ™ V3.2.0is a software onlydevice resident on theNEUWAVEMicrowave AblationSystem. Cybersecurityupdates were made tosoftware V3.2.0 on theNEUWAVEMicrowave AblationSystem. Cybersecurityupdates in V3.2.0software on theNEUWAVEMicrowave AblationSystem include:● WhitelistingAmendments● Shell LockdownAmendments● Firewall RuleAmendments● Bitlocker● Remove RemoteCode● ComponentRemovalCleanup | Ablation ConfirmationV3.1.0 is a software onlydevice resident on theNEUWAVE MicrowaveAblation System.Cybersecurity controls inV3.1.0 software on theNEUWAVE MicrowaveAblation System include:● Whitelisting● Shell Lockdown● Firewall | Similar.The NEUWAVEMicrowave AblationSystem software V3.2.0includes newcybersecurity features foradditional protection andcompliance. |
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Non-Clinical and/or Clinical Tests Summary & Conclusions
ABLATE-IQ™ was tested in accordance with an established test plan that fully evaluated all functions performed by the software. Design verification documents were developed to provide evidence for unit, integration, system level, regression, information security, and validation software tests. Additionally, User Requirement, Design Requirement, and Design Specification testing was reports were developed. The ABLATE-IQ™ software passed all pre-determined acceptance criteria identified in the test plan.
Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfills the requirements of FDA "Guidance on Software Contained in Medical Devices". Potential risks arising from the new or updated features were analyzed and satisfactorily mitigated in the device design and labeling.
ABLATE-IQ™ software V3.2.0 is substantially equivalent in design concepts, technologies and operating principle to the identified predicate. This version of the ABLATE-IQ™ does not present any new questions of safety or effectiveness.
Conclusion
The subject device, ABLATE-IQ™ software version 3.2.0, has the same or similar technological characteristics as the predicate device and therefore is substantially equivalent to the predicate device. Based on the intended use, technological characteristics, and non-clinical performance data, the modified software of ABLATE-IQ™ is substantially equivalent to the predicate device.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.